o Under “Recalls and Alerts”, click on “Warning Letters” o Under “Ways to View/Browse Warning Letters”, type GLP in the search box. Click on “Search”.
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o Examine the table showing the “Warning Letters Search Results”. What are the different centers (3) in the FDA that that issue GLP warning letters?
Summarize and comment on specific GLP violations by SNBL in the warning letter (specific actions/activities or lack thereof).
o From the first paragraph, the inspections are conducted as part of which FDA program?
o Which personnel has “primary responsibility to establish appropriate policies and procedures intended to ensure the quality and integrity of nonclinical safety data for FDA submission”?
o Within how many business days of the Warning Letter receipt is SNBL supposed to respond to the FDA issues?